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Low Rectal Cancer Study (MERCURY II) (MERCURY II)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02005965
First Posted: December 9, 2013
Last Update Posted: March 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pelican Cancer Foundation
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust
  Purpose

The MERCURY Study demonstrated the accuracy, feasibility and reproducibility of Magnetic Resonance Imaging (MRI) to stage rectal cancer in a prospective, multidisciplinary, multi-centre study. However, there were differences in patient outcome, dependent upon the position of the tumour in the rectum and its height above the anal verge. Whilst the outcome was excellent for patients who underwent an anterior resection, the outcome, based upon margin involvement and quality of the specimen, was poor for patients who underwent an abdomino-perineal excision for low rectal cancer.

It is proposed that accurate MRI staging pre-operatively will allow the correct patients to receive neo-adjuvant chemoradiotherapy (CRT), and also pre-warn the surgeons if the resection margins appear threatened so that the operation can be modified to take this into account. The primary aims of the Low Rectal Cancer Study (MERCURY II) are to assess the rate of CRM positivity rate in low rectal cancer and to assess the difference in global quality of life at two years post surgery in patients according to plane of surgery with or without sphincter preservation.


Condition
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Low Rectal Cancer Study.

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • To assess the rate of CRM positivity rate in low rectal cancer. [ Time Frame: 4 years ]
  • To compare global quality of life at two years post surgery in patients according to plane of surgery with or without sphincter preservation. [ Time Frame: 8 years ]

Secondary Outcome Measures:
  • To compare patient reported outcomes in patients according to plane of surgery with or without sphincter preservation. [ Time Frame: 8 years ]
  • Analysis of the clinical and radiological factors influencing the decision by surgeons to carry out Anterior Resections, APE or extralevator APE. [ Time Frame: 8 years ]
  • Comparison of time to local recurrence, disease-free and overall survival between patients undergoing different types of surgery. [ Time Frame: 8 years ]
  • Comparison of imaging and pathology staging assessment, patient characteristics and complication rates, between different types of surgery and surgical approaches. [ Time Frame: 8 years ]
  • Investigation of potential associations between imaging and pathology assessment of radial and distal margins, neo-adjuvant chemoradiotherapy, perineal complications and sphincter preservation rates. [ Time Frame: 8 years ]
  • Investigation of potential association between length of operation with number of complications and length of post-operative ITU/HDU stay. [ Time Frame: 8 years ]

Enrollment: 542
Study Start Date: September 2007
Estimated Study Completion Date: March 2020
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Staging and outcomes for patients with Low Rectal Cancer
Low Rectal Cancer defined on MRI as a cancer within 6cm of the anal verge

Detailed Description:
The aim of this study is to reduce the positive margin rate of 30% to around 15%. The study is an international multicentre, prospective, observational study, whereby patients with biopsy-proven low-rectal cancer (lower edge of the tumour < 6cms from the anal verge on MRI), will be recruited from participating centres, having given informed, written consent. Data from the radiology, surgical and pathological aspects will be collected and analysed centrally at the Royal Marsden Hospital. The patient's medical records will be reviewed for five years post surgery, and the patients will also be followed up by quality of life questionnaires. This project aims to show that in low rectal cancer, improved local control and survival can be achieved through a reduction in the involved CRM rates by MRI-planned surgery and selective pre-operative therapy. It also aims to assess the ability to predict disease recurrence and to provide an assessment of disease-free survival and overall survival.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with biopsy proven adenocarcinoma within 6cm of the anal verge confirmed on MRI.
Criteria

Inclusion Criteria:

  • Ability to give informed, written consent.
  • Adults age 18 or over - male or female.
  • Recently diagnosed with biopsy-proven, primary, low rectal cancer.
  • No previous therapy for rectal cancer.

Exclusion Criteria:

  • Current pregnancy, including ectopic pregnancy.
  • Previous pelvic/rectal malignancy (excluding carcinoma in-situ).
  • Previous pelvic radiotherapy.
  • Previous pelvic floor surgery for faecal incontinence or prolapse.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005965


Locations
Germany
Vivantes Klinikum im Friedrichshain
Berlin, Germany, 10249
Krankenhaus Dresden-Friedrichstadt
Dresden, Germany, 01067
Serbia
The First Surgical Clinic
Belgrade, Serbia, 11000
United Kingdom
Milton Keynes General Hospital
Milton Keynes, Buckinghamshire, United Kingdom, MK6 5LD
Stepping Hill Hospital
Stockport, Cheshire, United Kingdom, SK2 7JE
North Hampshire Hospitals NHS Trust (Basingstoke Hospital)
Basingstoke, Hampshire, United Kingdom, RG24 9NA
West Middlesex University Hospital
Isleworth, Middlesex, United Kingdom, TW7 6AF
Weston General Hospital
Weston-super-Mare, Somerset, United Kingdom, BS23 4TQ
Croydon University Hospital
Croydon, Surrey, United Kingdom, CR7 7YE
Frimley Park Hospital NHS Foundation Trust
Frimley, Surrey, United Kingdom, GU16 7UJ
Princess of Wales Hospital
Bridgend, Wales, United Kingdom, CF31 1RQ
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Bradford Royal Infirmary
Bradford, West Yorkshire, United Kingdom, BD9 6RJ
Salisbury NHS Foundation Trust (Salisbury District Hospital)
Salisbury, Wiltshire, United Kingdom, SP2 8BJ
Ulster Hospital
Belfast, United Kingdom, BT16 1RH
Royal Marsden Hospital
London & Surrey, United Kingdom
North Manchester General Hospital
Manchester, United Kingdom, M8 5RB
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Pelican Cancer Foundation
Investigators
Principal Investigator: Gina Brown Royal Marsden NHS Foundation Trust
Principal Investigator: Brendan Moran Pelican Cancer Foundation
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02005965     History of Changes
Other Study ID Numbers: CCR2943
First Submitted: November 21, 2013
First Posted: December 9, 2013
Last Update Posted: March 14, 2016
Last Verified: March 2016

Keywords provided by Royal Marsden NHS Foundation Trust:
Rectal Cancer
Low Rectal Cancer
MERCURY
Cancer
CRM
Circumferential Margin
Quality of Life
MRI
Radiology
Abdominoperineal Excision
Anterior Resection
Surgery
Pathology

Additional relevant MeSH terms:
Neoplasms
Adenocarcinoma
Rectal Neoplasms
Colorectal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Intestinal Diseases
Neoplasms by Histologic Type
Intestinal Neoplasms
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms, Cystic, Mucinous, and Serous
Adenocarcinoma, Mucinous
Carcinoma
Colonic Diseases